(42 days)
Use of Ceftaroline 30μg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ceftaroline. The concentration of 30μg has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA approved drug insert for this antimicrobic.
Active In Vitro and in Clinical Infections Against:
Gram-positive Microorganisms
Staphylococcus aureus (including methicillin-susceptible and -resistant isolates)
Streptococcus pyogenes
Streptococcus agalactiae
Streptococcus pneumoniae
Gram-negative Microorganisms
Escherichia coli
Klebsiella pneumoniae
Klebsiella oxytoca
Haemophilus influenzae
Active In Vitro Against:
Gram-positive Microorganisms
Streptococcus dysgalactiae
Gram-negative Microorganisms
Citrobacter koseri
Citrobacter freundii
Enterobacter cloacae
Enterobacter aerogenes
Moraxella catarrhalis
Morganella morganii
Proteus mirabilis
Haemophilus parainfluenzae
Ceftaroline 30ug BBL" Sensi-Disc" is prepared by impregnating high quality paper with accurately determined amounts of Ceftaroline supplied by the drug manufacturer. Each Ceftaroline disk is clearly marked on both sides with the agent and drug content. Ceftaroline cartridges each contain 50 impregnated disks that are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Ceftaroline disks are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method.
Agar diffusion susceptibility methods employing dried filter paper disks impregnated with specific concentrations of antimicrobial agents were developed in the 1940s. In order to eliminate or minimize variability in the testing. Bauer et al. developed a standardized procedure in which Mueller Hinton Aqar was selected as the test medium.
Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the Clinical and Laboratory Standards Institute (CLSI) [Formerly National Committee for Clinical Laboratory Standards (NCCLS)] and is periodically updated.
This submission for the Ceftaroline 30µg BBL Sensi-Disc Antimicrobial Susceptibility Test Disks is for an in vitro diagnostic (IVD) device. The provided text outlines the intended use, device description, and comparison to a predicate device, focusing on its function in determining bacterial susceptibility to Ceftaroline. However, it does not contain a detailed study report with specific acceptance criteria and performance data in the format typically required for medical device clinical studies in the context of human imaging or diagnostic algorithms.
The document refers to the Ceftaroline drug package insert, "Microbiology" for "SUBSTANTIAL EQUIVALENCE TESTING DATA." This indicates that the performance of the antimicrobial susceptibility test disk is tied to the established performance and microbiology data of the Ceftaroline drug itself, which would have undergone rigorous clinical trials for its efficacy and determination of susceptibility breakpoints. The 510(k) submission is confirming that the method of testing (using the Sensi-Disc) provides results consistent with the drug's known microbiological profile.
Therefore, many of the requested points cannot be directly answered from the provided text, as they pertain to a different type of device evaluation (e.g., studies involving human readers, imaging data, or AI algorithms).
Here's a breakdown of what can be inferred or directly stated from the provided document, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance in terms of sensitivity, specificity, accuracy, or other typical metrics for a diagnostic algorithm. Instead, for IVD susceptibility testing, the acceptance criteria are based on comparing zone sizes around the disk to established zone size ranges for individual antimicrobial agents, which are determined by the antimicrobic manufacturer and FDA approved under the drug's NDA (Number 200327). These are also guided by CLSI/NCCLS standards (M2 and M100). The "performance" of the device is its ability to produce inhibition zone diameters that consistently fall within these established ranges for control organisms and accurately categorize clinical isolates as Susceptible (S), Intermediate (I), or Resistant (R) according to the FDA drug insert and CLSI/NCCLS documents.
Specific performance data for this device is explicitly stated to be in the Ceftaroline drug package insert, "Microbiology." Therefore, a table of this data cannot be created from the provided text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. It would be contained within the "Microbiology" section of the Ceftaroline drug package insert. For antimicrobial susceptibility testing, the "test set" would typically consist of a variety of bacterial isolates, including both wild-type and resistant strains, collected from various clinical sources.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. For antimicrobial susceptibility testing, "ground truth" is typically established by reference methods like broth microdilution or agar dilution as defined by CLSI. The establishment of these reference values usually involves a consensus process by expert microbiologists and laboratory professionals within organizations like CLSI. It isn't tied to individual experts interpreting results, but rather to standardized laboratory procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided. Adjudication methods like 2+1 are typically used in scenarios where human interpretation of complex data (e.g., medical images) needs consensus. For antimicrobial susceptibility testing, the measurement of inhibition zones is objective, and interpretive categories (S/I/R) are determined by comparing measurements to predefined breakpoints, not by expert consensus on each individual test result.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable and not provided. The device is a physical disk for manual susceptibility testing, not an AI-powered diagnostic tool. Therefore, MRMC studies, human reader improvement with AI, or effect sizes related to AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical Sensi-Disc; it is not an algorithm. The "algorithm" for interpretation involves measuring a zone diameter and comparing it to a published table, which inherently involves human observation and measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for antimicrobial susceptibility testing is established by reference methods such as broth microdilution or agar dilution, which determine the Minimum Inhibitory Concentration (MIC) of the drug against a particular bacterial isolate. These reference methods are standardized by organizations like CLSI and are based on extensive microbiological data. The zone diameter breakpoints for the Sensi-Disc are then correlated to these reference MIC values.
8. The sample size for the training set
This information is not explicitly provided. For IVD devices like this, the "training set" doesn't refer to an AI training set. Instead, it refers to the collection of bacterial isolates used during the development and validation of the disk diffusion method and the establishment of interpretive zone diameter breakpoints. This data would be found in the microbiological studies supporting drug approval and CLSI guidelines.
9. How the ground truth for the training set was established
Similar to point 7, the "ground truth" for establishing the correlation between zone diameters and MICs (which leads to the S/I/R interpretive categories) is based on standardized reference antimicrobial susceptibility testing methods (e.g., broth microdilution or agar dilution) performed on a large collection of characterized bacterial isolates. These methods provide the MIC values, against which the zone diameters from the disk diffusion method are correlated. This process is outlined in CLSI guidelines and validated during the drug approval process.
§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).